Bio Soft Research offers a complete pharmaceutical regulatory affairs support service during pharmaceutical development to assist in the implementation of a global regulatory strategy. The role of Bio Soft Research staff is to tell you the current standards for your development regulatory submissions, and what you need to do to meet them. We explain why you need to do what needs to be done, and help you to generate data which will successfully meet the requirements.

Our services include:

    • Development, preparation, assembly and submission of complete Common Technical Documentation (CTD) for marketing authorization applications (MAAs) in India, Europe and the USA.
    • Orphan drug designation/applications
    • Conversion of paper or NEES documents into electronic dossiers using e-CTD (electronic Common Technical Document) software.
    • Preparation of responses to regulatory authorities, comment letters, and assessment reports.
    • Provision of support for scientific advice meetings, representation to regulatory agencies and meeting planning.
    • Preparation and submission of Indian clinical trial authorization (CTAs) applications.
    • Risk management plans.
    • Due diligence and data evaluations.

    • Pharmaceutical regulations impact on all areas of drug development, manufacture, control and supply, from the early stages of drug development, through to dossier submission, approval and marketing. Bio Soft Research pharmaceutical regulatory affairs consultants have the experience to take a broad view of the development process. This means we are well-equipped to tailor pivotal submission documentation to facilitate a company's chances of achieving optimum product information. Post submission, Bio Soft Research can assist the client in responding to questions raised by regulatory agencies. Bio Soft Research will review all questions and examine submitted data and we will work with agencies on your behalf to ensure an optimum path to market.